Reported Jan 23, 2013 · Terminated
Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081,…
Bausch and Lomb, Incorporated
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch and Lomb, Incorporated · 30 Enterprise Ste 450 · Aliso Viejo, CA · 92656-7115
Is this the product you have?
- Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
- Lot codes and dates
- Lot Numbers23632, 23633, 23639, 23640, 23647, 23801, 23811, 23863, 23886, 23897, 23920, 23933, 23972, 24022, 24025, 24028, 24257, 24323, 24436, B100003C, B100003E, B100003G, B100015A, B100015D, B100023A, B100023B, B100023C, B100023D, B100023E, B100039C, B100039D, B100039F, B100046A, B100046B, B100046C, B100058A, B100069A, B100069E, B110027D, B110028C, B110048A, B110048D, B110056A, B120011D, B120016A, B120046C, C100039A, C100039B, C10003B, C100046A, C100046B, C100046C, D090095B, D090096A, D090096C, D090097C, D090097D, D090097E, D090097G, D090105B, D090105C, D090105D, D100007B, D100007C, D100008A, D100008B, D100009A, D100011A, D100011B, D100011C, D100016A, D100016B, D100016C, D100016D, D100022A, D100022B, D100022C, D100022D, D100026A, D100026B, D100026C, D100026D, D100026E, D100030A, D100030B, D100030C, D100035A, D100035B, D100035C, D100035D, D100043A, D100043B, D100043C, D100044A, D100044B, D100044C, D100044D, D100044E, D100045A, D100045B, D100045C, D100045D, D100059A, D100059B, D100059C, D100060A, D100060B, D100061A, D100061B, D100080A, D100081A, D100081AR, D100081AS, D110015A, D110015B, D110016A, D110045A, D110046A, D110047A, D110070A, D110071A, D110072A, D110090A, D110090B, D110091A, D110092A, D110108A, D110108B, D110108BR, D120015A, D120015B, D120027A, D120028A, D120029A, D120029B, D120038B, D120039A, D120056B, D120068A, D120068B, E090105A, E100016A, E100016B, E100035A, E100035B, E100035C, E100045A, E100045B, E100059A, E100059B, E100060A, E100060B, E100060C, E100061A, Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L)
- Amount recalled
- 2,515,760
Where it was sold
Why it was recalled
Stop using this product now
Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents, detachment has resulted in serious patient injury.
Using this product could cause serious injury, illness or death — stop using it now.
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